Androgenetic Alopecia and the JAK-STAT Pathway

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Brief Title

Androgenetic Alopecia and the JAK-STAT Pathway

Official Title

Assessment of the Role of the JAK-STAT Pathway in the Pathogenesis of Male Androgenetic Alopecia

Brief Summary

      It is a well known fact that the JAK-STAT pathway plays a pivotal role in the pathogenesis of
      alopecia areata. Both phosphorylated STAT 1 and 3 have been found to be upregulated in the
      disease. However, whether this pathway plays a role in other hair loss disorders remains
      unclear. The study aims at assessing STAT3 levels in male patients with androgenetic
      alopecia. The investigators hypothesize that STAT3 levels will be elevated (due to a previous
      study proving that JAK-STAT pathway is involved in non-immune mediated hair loss in mice.
    

Detailed Description

      Background and rationale Androgenetic alopecia occurs in men and women,and is characterised
      by the loss of hair from the scalp in a defined pattern. Determining factors appear to be
      genetic predisposition coupled with the presence of sufficient circulating androgen.

      The transformation of testosterone into dihydrotestosterone(DHT) by type 2 5-alpha reductase,
      which causes hair miniaturization,is universally accepted as the main player in the disease's
      pathogenesis. Nonetheless,how DHT causes hair thinning is not well understood. New studies
      revealed that a lymphocytic microfolliculitis targeting the bulge epithelium along with
      deposits of epithelial basement membrane zone immunoreactants are frequent findings in
      androgenetic alopecia and could point toward an immunologically driven trigger.

      Tyrosine kinases (TKs) are enzymes involved in intracellular signaling that catalyze the
      phosphorylation of tyrosine residues on protein substrates. They are key components of
      signaling pathways that drive any array of cellular responses including proliferation,
      differentiation, migration and survival. Janus kinases (JAKs) are specific TKs.

      Signal transducer and activator of transcription (STAT) proteins are transcription
      factorsprimarily phosphorylated and activated by JAKs.The JAK-STAT pathway is utilized by
      cytokines including interleukins (ILs), interferons (IFNs), and other molecules to transmit
      signals from the cell membrane to the nucleus. Growing evidence suggests that JAK inhibitors
      are efficacious in atopic dermatitis, alopecia areata, psoriasis and vitiligo.

      It is a well known fact that the JAK-STAT pathway plays a pivotal role in the pathogenesis of
      alopecia areata. Both phosphorylated STAT 1 and 3 have been found to be upregulated in the
      disease. However, whether this pathway plays a role in other hair loss disorders remains
      unclear. A study showedthat topical treatment of mouse and human skin with small molecule
      inhibitors of the JAK-STATpathway resulted in rapid onset of anagen and subsequent hair
      growth. It was shown that JAK inhibition regulates the activation of key hair follicle
      populations such as the hair germ. These findings indicate that the JAK-STAT pathway may be
      involved, not only in immune-mediated hair loss (alopecia areata), but also in the normal
      hair cycle.

      This current study aims at assessing STAT3 levels in patients with androgenetic alopecia, in
      an attempt to detect a possible role of the JAK-STAT pathway in the pathogenesis of the
      disease.

      Objective:

      The objective is to compare tissue levels of STAT3 in androgen-dependant areas in male
      androgenetic alopecia patients with their level in non-involved, non-androgen dependant areas
      (occipital scalp) in the same subjects.

      Population of study & disease condition (e.g women with hepatitis, ............) Males with
      androgenetic alopecia

      Background and demographic characteristics( e.g age,.......)

        -  Age above 18 years.

        -  Males

      Interventions :

      Each subject will be subjected to:

        -  Informed consent.

        -  Detailed history and clinical evaluation to determine severity of disease.

        -  Punch biopsies (1mm) of affected area of scalp (androgen dependent area) from 25
           patients with androgenetic alopecia.

        -  Punch biopsies(1mm) of normal area of scalp from occipital scalp (non-androgen dependent
           area) from the same 25 patients

        -  Quantification of STAT3 by polymerase chain reaction (PCR).

      Sample size (number of participants included)

        -  25 participants (That will serve as both patients and controls)

        -  Sample size calculation was done using G ⃰ Power 3.1.9.2.

      Possible. Risk Bleeding, secondary infection, scarring.
    


Study Type

Observational


Primary Outcome

Different in STAT3

Secondary Outcome

 Correlating STAT3 with severity

Condition

Androgenetic Alopecia

Intervention

Punch skin biopsy

Study Arms / Comparison Groups

 Androgenetic alopecia patients
Description:  Two 1 mm scalp punch skin biopsy will be taken per patient

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

25

Start Date

October 15, 2018

Completion Date

December 1, 2019

Primary Completion Date

December 1, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Males with androgenetic alopecia not receiving topical treatment nor systemic
             treatment for hair loss for at least 6 month prior to the study

        Exclusion Criteria:

          -  Patients with localized or generalized hair loss due to causes other than androgenetic
             alopecia.
      

Gender

Male

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Akmal S Hassan, MD, , 

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT03694067

Organization ID

Atm567


Responsible Party

Principal Investigator

Study Sponsor

Cairo University


Study Sponsor

Akmal S Hassan, MD, Study Director, Cairo University


Verification Date

January 2020